Shanghai Pharmaceuticals industry park design (Shanghai Pharma)

Fast-ex­pand­ing Shang­hai Phar­ma breaks ground on $1.8B biotech park fo­cused on next-gen R&D, an­ti­body pro­duc­tion

One of Chi­na’s biggest bio­phar­ma com­pa­nies is hit­ting the ground run­ning in 2021.

Shang­hai Phar­ma­ceu­ti­cals broke ground Mon­day on a $1.8 bil­lion, 3.2 mil­lion-square-foot in­dus­tri­al park ded­i­cat­ed to R&D work in the bustling field of cell and gene ther­a­pies as well as man­u­fac­tur­ing ther­a­peu­tic an­ti­bod­ies, the firm said.

The mas­sive site is lo­cat­ed in Pudong New Area’s Zhangjiang area and will see con­struc­tion take place in two phas­es — 1.08 mil­lion square feet for the first, and 2.15 mil­lion square feet for the sec­ond. News of the ground­break­ing and ex­pan­sion project was first re­port­ed by SHINE, a dig­i­tal news out­let of the Shang­hai Dai­ly.

Zuo Min, Shang­hai Phar­ma’s ex­ec­u­tive di­rec­tor and pres­i­dent, said the bio­phar­ma in­dus­try park will fea­ture both in­no­va­tion-in­cu­ba­tion-ser­vice and in­dus­tri­al­iza­tion plat­forms to help star­tups com­mer­cial­ize lab re­search projects, SHINE re­port­ed.

“The new site could great­ly ex­pe­dite new drug re­search and the com­mer­cial­iza­tion process in Shang­hai, mak­ing the city more at­trac­tive for new re­search projects from home and abroad,” Zuo said.

The in­cu­ba­tion plat­form will cov­er rough­ly 538,000 square feet while an­oth­er 861,000 square feet will be al­lo­cat­ed for an­ti­body man­u­fac­tur­ing fa­cil­i­ties, the com­pa­ny said. The to­tal vol­ume of an­ti­body re­ac­tors is ex­pect­ed to reach 120,000 liters.

Shang­hai Phar­ma’s man­u­fac­tur­ing ca­pac­i­ties cur­rent­ly fo­cus on ther­a­peu­tics in on­col­o­gy, cere­bro­car­dio­vas­cu­lar dis­eases, CNS drugs, and im­munol­o­gy, among oth­er ar­eas.

Over the past three years, the com­pa­ny has worked to ex­pand not on­ly in Chi­na, but in the US and Eu­rope as well. In 2018, the com­pa­ny pub­li­cized its in­tent to hunt for Amer­i­can man­u­fac­tur­ing and R&D cor­po­ra­tions that it could part­ner with and ac­quire Chi­na rights from to bol­ster its dis­tri­b­u­tion busi­ness.

As part of those ef­forts, the com­pa­ny opened a fa­cil­i­ty in San Diego in 2018, which has quick­ly launched ef­forts in myr­i­ad on­col­o­gy drug and an­ti­body pro­grams.

Shang­hai’s pipeline in­cludes cirm­tuzum­ab, a mon­o­clon­al an­ti­body drug that tar­gets man­tle cell lym­phoma and chron­ic lym­pho­cyt­ic leukemia, in Phase I/II clin­i­cal tri­als, ac­cord­ing to the con­glom­er­ate’s web­site. It al­so has TK216, a small mol­e­cule seek­ing to tar­get Ew­ing sar­co­mas—which present as pe­di­atric bone and soft tis­sue can­cer— in a Phase I study in pa­tients with re­lapsed or re­frac­to­ry Ew­ing sar­co­mas.

The drug­mak­er is al­so in pre­clin­i­cal de­vel­op­ment of ROR1 CAR-T, a cell ther­a­py which doesn’t at­tack healthy cell tis­sue but may pro­vide im­mune re­spons­es to can­cer­ous cells in hema­to­log­ic and sol­id tu­mors. The San Diego site is aid­ing its Shang­hai home base with test­ing and de­vel­op­ment of On­corine, or on­colyt­ic virus­es, which pref­er­en­tial­ly in­fect and kill can­cer cells.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Like the flu vac­cine every year, the FDA could move quick­ly on a vari­ant-tar­get­ed Covid vac­cine

In the same way that the FDA signs off on flu vaccines every year without requiring large clinical trials to measure their efficacy, the FDA may employ a similar strategy in authorizing variant-focused versions of the mRNA vaccines.

As the world braces for more data on the latest variant Omicron, which may reduce vaccine efficacy, top vaccine developers like Moderna and Pfizer-BioNTech have promised they can pull together a new vaccine targeted against a specific Covid variant in about 100 days. Since Omicron emerged last week, Pfizer-BioNTech, Moderna and J&J have all said they’ve begun work on Omicron-specific vaccines, if needed.

Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

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Nev­er too late: For­bion pitch­es $100M SPAC; Kro­nos Bio re­leas­es ear­ly in­ter­im da­ta on CDK9 in­hibitor

Dutch VC Forbion is hopping on the ever-lengthening SPAC train.

To be led by Jasper Bos, who joined Forbion Growth as a general partner back in May just after the fund closed at $428 million, Forbion European Acquisition will target late-stage opportunities in the life sciences industry in Europe to merge with and bring onto Nasdaq.

Cyril Lesser, senior controller at Forbion, will be the CFO while Bos serves as CEO.

Jeff Albers, Blueprint Medicines CEO

Look­ing past Big Phar­ma ri­vals, Blue­print buys a pre­clin­i­cal biotech for $250M+

J&J’s Rybrevant scored the first approval back in May for a small group of lung cancer patients with a rare EGFR mutation. Despite a swarm of other biopharma companies angling for a piece of that market, Blueprint Medicines is betting nearly $500 million on a candidate it thinks will stand out.

Blueprint is putting down $250 million in cash and another $215 million in biobucks for Lengo Therapeutics and its preclinical non-small cell lung cancer program LNG-451. Though it hasn’t been tested in humans, Blueprint says the candidate was “highly brain-penetrant” in preclinical trials, and has the potential to inhibit all common EGFR exon 20 insertion variants — which are found in just 2% to 3% of NSCLC patients.

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